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一项在晚期实体瘤受试者中评估YSCH-01瘤内注射的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
[Translation] An open-label, single/multiple-dose dose-escalation and dose-expansion clinical study to evaluate the safety/tolerability and preliminary efficacy of intratumoral injection of YSCH-01 in subjects with advanced solid tumors
主要目的
评价YSCH-01用于治疗复发/难治性晚期实体瘤受试者的安全性/耐受性。
确定YSCH-01临床推荐剂量。
次要目的
评价YSCH-01治疗复发/难治性晚期实体瘤的初步疗效。
评估YSCH-01的生物分布和病毒脱落情况。
评价接受YSCH-01受试者体内的药效学(PD)。
评价接受YSCH-01受试者体内的免疫原性。
初步评估YSCH-01对复发/难治性晚期实体瘤受试者生活质量的影响。
[Translation] Primary Objectives
Evaluate the safety/tolerability of YSCH-01 for the treatment of subjects with relapsed/refractory advanced solid tumors.
Determine the recommended clinical dose of YSCH-01.
Secondary Objectives
Evaluate the preliminary efficacy of YSCH-01 in the treatment of relapsed/refractory advanced solid tumors.
Evaluate the biodistribution and viral shedding of YSCH-01.
Evaluate the pharmacodynamics (PD) in subjects receiving YSCH-01.
Evaluate the immunogenicity in subjects receiving YSCH-01.
Preliminary evaluation of the effect of YSCH-01 on the quality of life of subjects with relapsed/refractory advanced solid tumors.
Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma:an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial
The target subjects were patients with histologically or cytologically confirmed recurrent glioblastoma.Six subjects were expected to be enrolled,the number of subjects will be adjusted according to the course and outcome of the trial.The aim of this study was to evaluate the safety and tolerability of recombinant L-IFN adenovirus injection in the treatment of patients with recurrent glioblastoma, and to determine the registered clinical recommended dose and dosing regimen.
Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study
This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection(YSCH-01) when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection
100 Clinical Results associated with Shanghai Yuan Song Biotechnology Co., Ltd.
0 Patents (Medical) associated with Shanghai Yuan Song Biotechnology Co., Ltd.
100 Deals associated with Shanghai Yuan Song Biotechnology Co., Ltd.
100 Translational Medicine associated with Shanghai Yuan Song Biotechnology Co., Ltd.